BIVIGAM

Product NDC: 76125-918
11-digit product format: 761250918
Labeler code: 76125
Product ID: 76125-918_f2d0d740-6f43-454c-9898-627be94f18e8
Type: PLASMA DERIVATIVE
Nonproprietary name: HUMAN IMMUNOGLOBULIN G
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: KEDRION BIOPHARMA, INC.
Application: BLA125389
Marketing category: BLA
Marketing start: 2013-02-04
Marketing end: 0000-00-00
Substance: HUMAN IMMUNOGLOBULIN G
Active strength: 1 g/10mL
Pharmacologic classes: Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	76125-918		I	Inactivated by FDA	2026-08-17
excluded package	package	76125-918	76125-918-04	I	Inactivated by FDA	2026-08-17
excluded package	package	76125-918	76125-918-09	I	Inactivated by FDA	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 66 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76125-918-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76125-918-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76125-918-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76125-918-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76125-918-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76125-918-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76125-918-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76125-918-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76125-918-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76125-918-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76125-918-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76125-918-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76125-918-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76125-918-04	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76125-918-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76125-918-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76125-918-09	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76125-918-04	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76125-918-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76125-918-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76125-918-09	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76125-918-04	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76125-918-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76125-918-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76125-918-09	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76125-918-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76125-918-09	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76125-918-04	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76125-918-09	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76125-918-04	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	76125-918-09	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	76125-918-04	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	76125-918-09	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	76125-918-04	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	76125-918-09	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	76125-918-04	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	76125-918-09	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	76125-918-04	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	76125-918-09	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	76125-918-04	`e2bbac7714bc…`	`27bdfed8d636…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76125-918-04	2020-01-31	C162847	48780-1	9d75b9d0-9d75-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use BIVIGAM safely and effectively. See full prescribing information for BIVIGAM. Immune Globulin Intravenous (Human), 10% Liquid BIVIGAM Initial U.S. Approval : 2012
76125-918-09	2020-01-31	C162847	48780-1	9d75b9d0-9d75-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use BIVIGAM safely and effectively. See full prescribing information for BIVIGAM. Immune Globulin Intravenous (Human), 10% Liquid BIVIGAM Initial U.S. Approval : 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76125-918-04	BIVIGAM	1 in 1 CARTON	INJECTION, SOLUTION	1	2
76125-918-05	BIVIGAM	50 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	50	2
76125-918-09	BIVIGAM	1 in 1 CARTON	INJECTION, SOLUTION	1	2
76125-918-10	BIVIGAM	100 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	100	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76125-918	BIVIGAM (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [KEDRION BIOPHARMA, INC.]	2	Legacy NDC, 4 package rows	20170201_00dd9bbb-ee8b-f369-8cd1-6ce28925f118.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BIVIGAM	IMMUNE GLOBULIN INTRAVENOUS (HUMAN) 10%	ADMA Biologics, Inc.	a2244aa0-a6d0-11df-b385-0002a5d5c51b	2025-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125389

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125389	Bivigam	Immune Globulin Intravenous (Human)	351(a)	Rx	2026-08-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
66Y330CJHS	HUMAN IMMUNOGLOBULIN G	308067-58-5	HUMAN IMMUNOGLOBULIN G

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1809422	Bivigam 10 % in 100 ML Injection	PSN	00dd9bbb-ee8b-f369-8cd1-6ce28925f118	2
1809416	Bivigam 10 % in 50 ML Injection	PSN	00dd9bbb-ee8b-f369-8cd1-6ce28925f118	2
1809421	immunoglobulin G, human 10 % in 100 ML Injection	PSN	00dd9bbb-ee8b-f369-8cd1-6ce28925f118	2
1809414	immunoglobulin G, human 10 % in 50 ML Injection	PSN	00dd9bbb-ee8b-f369-8cd1-6ce28925f118	2
1809422	100 ML immunoglobulin G, human 100 MG/ML Injection [Bivigam]	SBD	00dd9bbb-ee8b-f369-8cd1-6ce28925f118	2
1809416	50 ML immunoglobulin G, human 100 MG/ML Injection [Bivigam]	SBD	00dd9bbb-ee8b-f369-8cd1-6ce28925f118	2
1809421	100 ML immunoglobulin G, human 100 MG/ML Injection	SCD	00dd9bbb-ee8b-f369-8cd1-6ce28925f118	2
1809414	50 ML immunoglobulin G, human 100 MG/ML Injection	SCD	00dd9bbb-ee8b-f369-8cd1-6ce28925f118	2
1809422	100 ML Bivigam 100 MG/ML Injection	SY	00dd9bbb-ee8b-f369-8cd1-6ce28925f118	2
1809416	50 ML Bivigam 100 MG/ML Injection	SY	00dd9bbb-ee8b-f369-8cd1-6ce28925f118	2
1809422	Bivigam 10 % per 100 ML Injection	SY	00dd9bbb-ee8b-f369-8cd1-6ce28925f118	2
1809416	Bivigam 10 % per 50 ML Injection	SY	00dd9bbb-ee8b-f369-8cd1-6ce28925f118	2
1809422	Bivigam 10 GM per 100 ML Injection	SY	00dd9bbb-ee8b-f369-8cd1-6ce28925f118	2
1809416	Bivigam 5 GM per 50 ML Injection	SY	00dd9bbb-ee8b-f369-8cd1-6ce28925f118	2
1809421	immunoglobulin G, human 10 % per 100 ML Injection	SY	00dd9bbb-ee8b-f369-8cd1-6ce28925f118	2
1809414	immunoglobulin G, human 10 % per 50 ML Injection	SY	00dd9bbb-ee8b-f369-8cd1-6ce28925f118	2
1809421	immunoglobulin G, human 10 GM per 100 ML Injection	SY	00dd9bbb-ee8b-f369-8cd1-6ce28925f118	2
1809414	immunoglobulin G, human 5 GM per 50 ML Injection	SY	00dd9bbb-ee8b-f369-8cd1-6ce28925f118	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
76125-918-04	76125091804	1 in 1 CARTON		Historical
76125-918-05	76125091805	50 mL in 1 VIAL, GLASS	50 ml	Historical
76125-918-09	76125091809	1 in 1 CARTON		Historical
76125-918-10	76125091810	100 mL in 1 VIAL, GLASS	100 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BIVIGAM - KEDRION BIOPHARMA, INC. \| Biotest Pharmaceuticals Corporation	KEDRION BIOPHARMA, INC. \| Biotest Pharmaceuticals Corporation	2016-02-25	PLASMA DERIVATIVE	2